FDA Inspection
RC Outsourcing, LLCRC Outsourcing, LLC – FDA Inspection, Feb 9, 2016
Record Details
This FDA Inspection record concerns RC Outsourcing, LLC, with an inspection on February 9, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- RC Outsourcing, LLC
- Inspection Date
- February 9, 2016
- Product Type
- Drugs
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ID · 8a3b7863-9082-46ee-bd35-7a289492f2f7
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 959784
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
8- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 820.198(a)Complaints
- 21 CFR 211.167(a)Sterility/pyrogen-free testing
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- Drug product label, outsourcer facility
- 21 CFR 211.192Investigations of discrepancies, failures
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Other FDA inspections of RC Outsourcing, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| September 3, 2026 | Not classified | Cincinnati District Office | Drug Quality Assurance |
| August 28, 2025 | OAI | Cincinnati District Office | Drug Quality Assurance |
| September 27, 2024 | OAI | Cincinnati District Office | Drug Quality Assurance |
| September 23, 2022 | OAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 8, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
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